ObesePhase 3NCT04605861
The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients
A Phase 3 study testing Liraglutide in people with Obese and Overweight, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese or overweight adult patients with comorbidity of metabolic disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Overweight
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2020to 15 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those voluntarily participating and signing the ICF.
- Those aged 18-70 years old (including 18 and 70 years old), without restriction on male and female
- Those failing to control their body weight in previous diet therapy alone.
- Those voluntarily following the medication, diet and exercise requirements decided by the investigators.
- Those with a stable body weight (patient reported body weight change < 5 kg) in last 3 months.
- Those with BMI ≥ 30 kg/m2 (obese) or BMI ≥ 27 kg/m2 (overweight) accompanied by at least one treated or untreated related metabolic abnormality (hypertension, dyslipidemia, type 2 diabetes). Those with untreated hypertension defined as SBP ≥ 140 mmHg or DBP ≥ 90 mmHg; untreated dyslipidemia defined as LDL-C ≥ 4.1 mmol/L, TG ≥ 1.7 mmol/L, TC ≥ 5.7 mmol/L or HDL-C < 1.0 mmol/L in male and < 1.3 mmol/L in female.
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- Those with type 2 diabetes should additionally meet the following inclusion criteria:
- Those diagnosed as type 2 diabetes according to WHO (1999) Diagnostic and Classification Criteria at the time of screening;
- Those receiving diet and exercise therapy alone, or receivig metformin, sulfonylureas, glycosidase inhibitors and glinides alone or in combination on the basis of diet and exercise therapy, with their treatment remaining stable at least 3 months before screening (with original documents such as prescriptions provided);
- Those with HbA1c of 7.0-10.0% (inclusive);
- Those with FPG < 13.3 mmol/L (240 mg/dL).
Who cannot join
- Subjects who meet one of the following exclusion criteria will be excluded.
- Those with type 1 diabetes or secondary diabetes.
- Those with acute metabolic complications such as diabetic ketoacidosis or hyperglycemia (coma) within 6 months before screening.
- Those with 2 or more severe hypoglycemia events (hypoglycemia with severe cognitive impairment and need other measures to help them recover) without obvious inducement within 3 months before screening.
- Those receiving GLP-1 receptor agonist, DPP-4 inhibitors, SGLT-2 inhibitor, or insulin therapy within 3 months prior to screening.
- Those with obesity caused by endocrine diseases such as Cushing's syndrome.
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- Patients taking drugs that can significantly increase weight in the 3 months before screening, including systemic glucocorticoid (except cumulative or continuous use of less than 14 days).
- Those using OTC weight-loss drugs or appetite inhibitors (including traditional Chinese medicine as weight-loss drugs) within 1 month before screening, or use prescription weight-loss drugs (such as fentanyl, sibutramine, orlistat) or lipid dissolving injection (such as fat dissolving needle) within 3 months before screening.
- Those with binge eating behavior in the past, that is, eating a large amount of food in a short period of time with a sense of loss of control.
- Those who have treated or plan to treat obesity (during the trial) with surgery or body weight loss devices.
- Those with a past or family history of MTC (grandparents, parents, siblings), or those whose genetic diseases are prone to induce MTC and MEN2.
- Those with thyroid nodules of unknown etiology at the time of screening which is considered clinically significant by the investigator (calcitonin is more than 50 pg/ml, which is only allowed to be retested once).
- Those with a past history or found to have hyperthyroidism or hypothyroidism or subclinical hypothyroidism at the time of screening [TSH > 6 mIU/L].
- Those with history of pancreatic cancer, acute or chronic pancreatitis, or with acute or chronic pancreatitis at the time of screening, or having blood amylase or lipase ≥ 3 times ULN.
- Those with acute gallbladder disease (cholecystitis, gallstone) more than 2 times in 1 year before screening.
- Those with MDD, anxiety disorder or other mental illnesses or with the PHQ-9 score ≥ 15 at screening
- Those with the following cardiovascular and cerebrovascular diseases within 6 months before screening: decompensated cardiac insufficiency (NYHA Class III-IV), UA or AMI, CVA or stroke.
- Those with a history of heart valve replacement, CABG or other PTCA including percutaneous coronary intervention.
- Those who fail to control their blood pressure effectively, with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg.
- Those with a history of malignancy in the past 5 years, not including cervical epithelial carcinoma, squamous cell carcinoma or basal cell carcinoma of skin that have been clinically cured within 5 years.
- Those with known proliferative retinopathy or maculopathy.
- Those with a history of major surgical operations (intrathoracic, intracranial, intraperitoneal, etc.) within 6 months, or planning to perform operations that may interfere with the completion or compliance of the study.
- Those with a history of organ transplantation.
- Those with ADIS or syphilis at the time of screening, or whose serum virological test shows hepatitis C virus antibody or hepatitis B surface antigen and hepatitis B core antibody are positive at the time of screening.
- Those with AST or ALT > 3.0-fold ULN, or total bilirubin > 2.0-fold ULN at the time of screening.
- Those with eGFR < 60 mL/min/1.73 m2 at the time of screening.
- Those with a history of drug abuse (heavy and repeated use of dependent drugs or substances not related to medical purposes, including addictive and habitual drugs, causing physical and mental dependence) in 5 years before screening and alcohol dependence (long-term heavy drinking, causing physical and mental dependence, male drinking more than 14 units of alcohol per week, and female drinking more than 7 units per week) (1 unit alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine)].
- Female who are known to be pregnant (determined by pregnancy test at the time of screening) or who are breast-feeding or who plan a pregnancy during the study and are unwilling to take effective contraceptive measures (including partners).
- Those participating in other intervention clinical trials within 3 months prior to screening.
- Those known to be allergic to GLP-1 receptor agonist.
- Those with any serious systemic diseases as determined by the investigator, or other diseases as believed by the investigator to be possible to interfere with the results of this study or abnormal laboratory tests with clinical significance.
- Those who, according to the opinion of investigators, are not suitable to participate in clinical trials, including those who are physically or psychologically unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese or overweight adult patients with comorbidity of metabolic disorders.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening period, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up period. Subjects with obesity or overweight with comorbidity of metabolic disorders receive subcutaneous injection of 3.0 mg Liraglutide or placebo every day. The primary endpoint is the change of body weight or the percentage of body weight loss greater than 5%. The changes of body weight between Liraglutide Injection group and placebo group will be compared. In the course of the trial, the subjects are weighted on fasting state. Blood samples are collected according to the protocol. All subjects receive lifestyle intervention, including a reductiong of calorie intake by 500 kcal a day and physical exercise.
- Conditions
- Obese, Overweight
- Being tested
- Liraglutide, Placebo
- Keywords
- weight loss, obeses, overwweight, Liraglutide
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Liraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
PlaceboDrug
Placebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Liraglutide Injection, once a day, injected subcutaneously on abdomen, thigh or upper arm. Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | Placebo (Liraglutide Injection simulator), once a day, injected subcutaneously on abdomen, thigh or upper arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of body weight loss
The percentage of body weight loss from baseline to the end of treatment
Measured: through study completion, an average of 32 weeks
The proportion of body weight loss ≥ 5 percent
The proportion of subjects whose body weight loss is greater than ≥ 5 percent from baseline level to the end of treatment
Measured: through study completion, an average of 32 weeks
Secondary outcomes (9)
Changes in waist circumference
Changes in waist circumference of the subjects at the end of treatment
Measured: through study completion, an average of 32 weeks
Changes in diastolic pressure and systolic pressure
Changes in blood pressure level (diastolic pressure and systolic pressure) of the subjects at the end of treatment
Measured: through study completion, an average of 32 weeks
Changes in pulse of the subjects
Changes in pulse of the subjects at the end of treatment
Measured: through study completion, an average of 32 weeks
The changes in blood lipid
The changes in blood lipid levels (triglyceride, total cholesterol, low density lipoprotein cholesterol, and high density lipoprotein cholesterol) of the subjects at the end of treatment
Measured: through study completion, an average of 32 weeks
The changes in blood glucose
The change in fasting blood-glucose of the subjects at the end of treatment
Measured: through study completion, an average of 32 weeks
The changes in HbA1c
The changes in HbA1c of patients with type 2 diabetes at the end of treatment
Measured: through study completion, an average of 32 weeks
Absolute body weight change
The absolute body weight loss of the subjects at the end of treatment
Measured: through study completion, an average of 32 weeks
The proportion of body weight loss > 10 percent
The proportion of subjects with body weight loss > 10 percent at the end of treatment
Measured: through study completion, an average of 32 weeks
The changes in IWQOL-lite
Effect of changes in body weight of the patients to the IWQOL-lite at the end of treatment
Measured: through study completion, an average of 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start18 Aug 2020
- Primary completion31 Dec 2022
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34\~36 weeks, including 2-week screening, 6\~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605861
- Sponsor's protocol ID
- JSWB-LRG2020-301
- Status last verified
- Jun 2023
- First submitted
- 8 Oct 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients
- ClinicalTrials.gov ID
- NCT04605861
- Acronym / sponsor ID
- JSWB-LRG2020-301
- Conditions
- Obese, Overweight
- Keywords
- weight loss, obeses, overwweight, Liraglutide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese or overweight adult patients with comorbidity of metabolic disorders.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening period, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up period. Subjects with obesity or overweight with comorbidity of metabolic disorders receive subcutaneous injection of 3.0 mg Liraglutide or placebo every day. The primary endpoint is the change of body weight or the percentage of body weight loss greater than 5%. The changes of body weight between Liraglutide Injection group and placebo group will be compared. In the course of the trial, the subjects are weighted on fasting state. Blood samples are collected according to the protocol. All subjects receive lifestyle intervention, including a reductiong of calorie intake by 500 kcal a day and physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up.
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideLiraglutide Injection, once a day, injected subcutaneously on abdomen, thigh or upper arm. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Liraglutide Injection simulator), once a day, injected subcutaneously on abdomen, thigh or upper arm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Those voluntarily participating and signing the ICF.
- Those aged 18-70 years old (including 18 and 70 years old), without restriction on male and female
- Those failing to control their body weight in previous diet therapy alone.
- Those voluntarily following the medication, diet and exercise requirements decided by the investigators.
- Those with a stable body weight (patient reported body weight change < 5 kg) in last 3 months.
Key exclusion criteria (32 listed)
- Subjects who meet one of the following exclusion criteria will be excluded.
- Those with type 1 diabetes or secondary diabetes.
- Those with acute metabolic complications such as diabetic ketoacidosis or hyperglycemia (coma) within 6 months before screening.
- Those with 2 or more severe hypoglycemia events (hypoglycemia with severe cognitive impairment and need other measures to help them recover) without obvious inducement within 3 months before screening.
- Those receiving GLP-1 receptor agonist, DPP-4 inhibitors, SGLT-2 inhibitor, or insulin therapy within 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideLiraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated. | Drug | Liraglutide |
| PlaceboPlacebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated. | Drug | Placebo |
Primary outcome
The percentage of body weight loss
Time frame: through study completion, an average of 32 weeks
The percentage of body weight loss from baseline to the end of treatment
The proportion of body weight loss ≥ 5 percent
Time frame: through study completion, an average of 32 weeks
The proportion of subjects whose body weight loss is greater than ≥ 5 percent from baseline level to the end of treatment
9 secondary outcomes
Changes in waist circumference
Time frame: through study completion, an average of 32 weeks
Changes in diastolic pressure and systolic pressure
Time frame: through study completion, an average of 32 weeks
Changes in pulse of the subjects
Time frame: through study completion, an average of 32 weeks
The changes in blood lipid
Time frame: through study completion, an average of 32 weeks
The changes in blood glucose
Time frame: through study completion, an average of 32 weeks
The changes in HbA1c
Time frame: through study completion, an average of 32 weeks
Absolute body weight change
Time frame: through study completion, an average of 32 weeks
The proportion of body weight loss > 10 percent
Time frame: through study completion, an average of 32 weeks
The changes in IWQOL-lite
Time frame: through study completion, an average of 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoying Li, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide in people with Obese and Overweight, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of body weight loss (time frame: through study completion, an average of 32 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.